the tolerability and effect of food on the pharmacokinetics of a single 800 mg oral dose of bia 2-093

Conditions: Epilepsy

Summary: the purpose of this study is to investigate the effect of food on the pharmacokinetics of a single 800 mg oral dose of bia 2-093 in healthy volunteers.

single centre, open label, randomized, two-way crossover study in 12 healthy male volunteers. the study consisted of 2 periods separated by a washout period of 14 days or more. on each of the study periods the volunteers received a single 800 mg oral dose of bia 2-093 following either a standard high fat content breakfast or 10 hours of fasting.

Eligibility criteria:
inclusion criteria: subjects were eligible for entry into the study if they fulfilled the following inclusion criteria: * male subjects aged between 18 and 45 years, inclusive. * subjects of body mass index (bmi) between 19 and 28 kg/m2, inclusive. * subjects who were healthy as determined by pre study medical history, physical examination, neurological examination, eeg, and 12-lead ecg. * subjects who had clinical laboratory tests clinically acceptable to the investigator. * subjects who were negative for hbsag, anti-hcv ab and hiv-1 and hiv-2 ab tests at screening. * subjects who were negative for alcohol and drugs of abuse at screening and admission. * subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day. * subjects who were able and willing to give written informed consent. exclusion criteria: * subjects who did not conform to the above inclusion criteria. * subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant atopy. * subjects who had a history of relevant drug hypersensitivity. * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 21 units of alcohol a week. * subjects who had a significant infection or known inflammatory process on screening and/or admission. * subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn). * subjects who had an acute infection such as influenza at the time of screening and/or admission. * subjects who had used prescription drugs within four weeks of first dosing. * subjects who had used over-the-counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing. * subjects who had used any investigational drug and/or participated in any clinical trial within two months of their first admission to this study. * subjects who had previously received bia 2-093. * subjects who had donated and/or received any blood or blood products within the previous two months prior to screening. * subjects who were vegetarians, vegans and/or had medical dietary restrictions. * subjects who could not communicate reliably with the investigator. * subjects who were unlikely to co-operate with the requirements of the study. * subjects who were unwilling or unable to give written informed consent.

Keywords: bia 2-093 eslicarbazepine acetate